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Vendor/CRO Oversight is sponsor responsibility and accountability. Vendor Oversight is a high level but an intellectual task which needs right plan, approach and good technology support to get real insights from huge data being generated and activities happening on a project/study. Appropriate oversight and adequate risk management are needed to ensure better compliance, higher quality, lower vendor risks, and to have better return on budgets.

Most sponsors either fail or fall short to achieve these objectives mainly due to lack of comprehensive oversight and risk management approach. Also, heavy-dependency on vendor for providing their own metrics and performance reports may be risky for sponsors. This webinar is planned to focus on vendor oversight plan, as well as strategies by identifying critical elements required and also aligning proper techniques of risk management.

Given the specialist nature of IRT systems, it is now almost impossible for mid and small-sized pharma companies, and biotechs, to develop or maintain bespoke, internally-managed IRT systems. Most company staffing protocols simply don’t allow for the kind of infrastructure necessary to maintain such a specialist team, so we must inevitably look elsewhere for specialist IRT service providers.

BUT..

What happens when individual study teams are given the responsibility to select and manage their own chosen IRT vendor? How often have we seen one team encountering seemingly insurmountable difficulties, leading any teams following in their footsteps to automatically reject that IRT vendor, select another and subsequently experience very similar problems? How much better could the experience be if we were to invest proper time and effort with a single selected vendor, over time learning from our mistakes, improving our procedures and passing on knowledge to the study teams following behind us?

What are the pitfalls when each team is allowed to select their own IRT vendor?

What does a good IRT vendor partnership look like?

What will we need to invest in order to develop a successful partnership?

As we move deeper into the 21st century, technologies available to clinical research teams are evolving at an ever-increasing rate. Whilst this evolution allows clinical trials to become increasingly smart and patient-centric it also runs the risk of making trials increasingly complicated with many more moving parts, third party vendors and data sources to integrate. With this in mind, how do we prevent these exciting new technologies that are designed to save us time and effort, from becoming the rate limiting steps in clinical trial set-up?

This webinar will examine both the stumbling blocks that have historically delayed the successful implementation of IRT systems and also new challenges that we increasingly face as the uptake in technological solutions intensifies. We will then explore some possible solutions; both quick-fixes and longer term strategies that will take IRT development off the table as a rate-limiting step in clinical trial set-up.

★ Understand the historical stumbling blocks that limit the speed of IRT set-up
★ Identify new challenges that emerge as technological solution uptake intensifies
★ Suggest some quick-fixes to see immediate improvements in development time
★ Explore potential longer-term strategies to reduce the build time of IRT

About Speaker:

Kate Chapman, the Director and Principal Consultant of Clinical Technology Consultants Ltd based in Winchester, UK, has 22 years of experience in the Clinical Development area of the Pharmaceutical and Biotechnology sector, having worked at multiple Pharma companies including Novartis, Roche, Sanofi, BMS, Pharmacia and Shire, and has a deep expertise in IRT. Kate has extensive experience of IRT systems and continuously reviews many of the systems that are currently available and those that are under development. In her capacity as consultant, she works with both large Pharma and small Biotech companies helping them to get the most out their IRT systems and their partnerships with a wide variety of IRT vendors.

Mahesh Malneedi speaking on “Presenting Trends and future outlook of Technology and its impact on Data analysis and Visualization” at ITCT2017 Congress

Mahesh Malneedi, President of DDi, is the key speaker at ITCT2017 Congress. He will be speaking on “Presenting Trends and future outlook of Technology and its impact on Data analysis and Visualization”. Technology has proliferated into Clinical trials a decade back. It is still debatable where it is making impact and where it is not. In this session Mahesh will be exploring some trends and future outlook of Technology and Tools in Data Analysis as well as Visualization.

The International Congress on IT & Software Solutions for Clinical Trials (ITCT2017) will take place 15-16 May 2017, in Amsterdam, Netherlands. Meet Mahesh and DDi Team to get more insight on the latest technology in Clinical Data Analysis.

The Innovation and Excellence awards is by far the most celebrated category in the Corporate LiveWire awards recognizing winners for their innovative ideas, global involvement, products, services and much more. The Innovation and Excellence Awards are sponsored by The International Business Innovation Association (InBIA), a global non-profit member network that serves a diverse group of 2,200+ entrepreneurship centers.

Elizabeth Moore, Awards Director of the 2017 Innovation & Excellence Awards commented on the stature of the winners: “I have seen a massive change in innovation going into 2017, billions have been spent in R&D and to work with the most influence people in the industry has been an experience to remember. Our winners have proven to overcome many economic changes and challenges including developments in legislation and politics. I would like to personally congratulate all of our winners and I look forward to seeing further success throughout 2017”.

The judging panel at Corporate LiveWire considered the strengths of each shortlisted candidate, setting its sights firmly on the most innovative, ground-breaking and client-focused firms, teams and individuals who have transformed the way in which they do business. Each winner was chosen on merit and has shown excellence, innovation and strong leadership throughout their various activities over the past calendar year.

DDi has been awarded as winner in Global Excellence in Life Science Technology by Corporate LiveWire for showing excellence by thinking innovatively and utilizing functional domain well, as well as significantly lowering data costs per patient.

DDi’s technology deals with massive data collected from multiple systems, posing the great challenge of maintaining data integrity and correctness. With a series of policies, processes, standards and tools in place, DDi is able to successfully manage their critical data. A move towards standardizing the data and incorporating checks and balances sees that incorrect data is prevented from entering their system and so DDi is able to offer insightful reports in a meaningful way, with correct metadata and mapping that ensures the data flow from source to destination is seamless and presented with utmost accuracy. Indeed, companies need the best IT systems and tools to manage their research and development, and DDi focuses on this highly specialized area, offering e-clinical products and solutions that enable clinical research and trial designs to work with high computing power and analysis.

The partner companies we work with are critical to our success and never more so than when we select and cooperate with an IRT service provider. With a little careful thought and a positive internal approach our partnerships can be streamlined, efficient and rewarding for both sponsor and IRT vendor alike resulting in better IRT systems, built more speedily, at reduced cost and with a fraction of the customary frustration and duplication of effort.

In this session, you’ll learn:

Appreciating the importance of positive vendor partnerships

Developing a streamlined sponsor/vendor relationship

A modern approach to UAT

Best practices for UAT and beyond

About Our Speaker:

Kate Chapman, the Director of Clinical Technology Consultants Ltd. and the Principal Consultant, Clinical Technology Consultants, Winchester, UK, has 19 years of experience in the Clinical Development area of the Pharmaceutical and Biotechnology sector, with a specialization in IRT. Kate has extensive experience as an end-user of IRT systems and continuously reviews many of the systems that are currently available. She worked with companies like Sandoz, Novartis, Innovex, Roche, Bristol Myers Squibb, Sanofi, Merck, Sharpe and Dohme, Pharmacia, PPD and Emergent Biosciences. Kate most recently formed and led an internal support function dedicated to IRT services and associated disciplines for Shire Pharmaceuticals.